The clinical study of patch graft using silk patch in the traumatic drum perforation and non-infectious chronic otitis media patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000305

Enrollment

Registered

2011-12-29

Start date

2011-04-22

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : In the patients with traumatic tympanic membrane perforations or non-infectious chronic otitis media, a classic local anesthesia is done under the operative microscope. The rim of the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Traumatic tympanic membrane perforation - Tympanic membrane perforation is caused by trauma within 2 weeks (2) Non-infectious chronic otitis media - The treated ears is free from infections and dry for at least 3 months before the patch application

Exclusion criteria

Exclusion criteria: (1) evidence of middle ear disease or active drainage (2) chronic mastoiditis (3) uncooperative patients (4) patients disagree with this study (5) more than 75% perforation (6) perforation including tympanic annulus, malleus umbo (7) disruption of the ossicles (8) allergy to silk fibroin

Design outcomes

Primary

Measure	Time frame
Healing rate of tympanic membrane perforation	—

Secondary

Measure	Time frame
Infection rate ;Hearing improvement ;Healing times of tympanic membrane perforation ;Complication	—

Countries

Korea, Republic of

Contacts

Public ContactJi Heui Kim

Hallym University Medical Center- Chuncheon

Outcome results